A Comparative Effectiveness Trial of Optimal Patient-Centered Care

NCT02274688 | Completed Results DMC

• 2 other identifiers: 46615-EJIH-1304-6319
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

The nation's trauma care system, which includes trauma center hospitals \& emergency departments, is where over 30 million Americans receive care after traumatic injuries each year. Injury victims are diverse patients who suffer from complications of the initial injury as well as from multiple complex medical \& mental health conditions. Currently, high-quality patient-centered care is not the standard of care throughout US trauma care systems. Injured trauma survivors treated in trauma care systems frequently receive fragmented care that is not coordinated across hospital, emergency department, outpatient, \& community settings. Post-injury care is frequently not individualized to integrate the patient's most pressing post-traumatic concerns \& preferences into medical decision making. The investigators, as a group of front-line trauma center providers, patients, researchers \& policy makers, have been working together for over a decade to integrate patient-centered care into US trauma care systems. The investigators began this work by asking groups of injured patients the key patient-centered question: "Of everything that has happened to you since your injury, what concerns you the most?" The investigators developed scientifically sound assessment tools that allowed us to follow patient concerns after injury hospitalization. In May of 2011, the investigators convened an American College of Surgeons' policy summit that addressed mental health \& patient-centered care integration across US trauma care systems. As part of this policy summit, patient members of our team presented their experiences of traumatic injury \& recovery. While giving injured patients a "voice" at the summit, these narratives did not move surgical policy makers to develop mandates or guidelines for patient-centered care. In contrast, presentations that included information from randomized comparative effectiveness trials \& standardized outcome assessments convinced surgical policy makers to develop US trauma care system policy mandates \& best practice guidelines for post-traumatic stress disorder \& alcohol use problems. Our team now realizes that in order to optimally integrate patient-centered care into US trauma care systems, the investigators must use the best scientific methods that capture the highest-quality data. This PCORI proposal aims to demonstrate that a patient-centered care management treatment that addresses patient's post-injury concerns \& integrates patient concerns \& preferences into medical decision making, while also coordinating care, can improve outcomes of great importance to patients \& their caregivers, front-line providers \& policy makers. This proposal directly addresses two PCORI patient-centered research questions: "After a traumatic injury, what can I do to improve the outcomes that are most important to me?" \& "How can front-line providers working in trauma care systems help me make the best decisions about my post-injury health \& health care?"

Conditions

Post Traumatic Concerns; Post Traumatic Stress Disorder; Depression and Suicide Ideation; Alcohol and Drug Use

Outcome Measures

Primary Outcomes (3)

• Change in Post Traumatic Concerns Over the Course of the Six Months After Injury

  The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.

  The investigators assessed at baseline, 1-, 3-, and 6-month.

• Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury

  The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minumum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.

  The investigators assessed at baseline, 1-, 3-, and 6-month.

• Change in Depression Symptoms Over the Course of the Six Months After Injury

  The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.

  The investigators assessed at baseline, 1-, 3-, and 6-month.

Secondary Outcomes (6)

• Alcohol Use Problems

  The investigators assessed at baseline, 1-, 3-, and 6-month.

• Functional Status

  The investigators assessed at baseline, 1-, 3-, and 6-month.

• Number of Participants With Suicidal Ideation

  The investigators assessed at baseline, 1-, 3-, and 6-month.

• Number of Patients Carrying a Weapon

  The investigators assessed at baseline, 1-, 3-, and 6-month.

• Number of Participants With One or More Emergency Department Visits Over Time

  The investigators assessed emergency department service use over the course of the study.

Study Arms (2)

Enhanced Usual Care - Nurse Notification of Patient Concerns

NO INTERVENTION

Randomized and will be blindly assessed.

Patient-centered care transition

EXPERIMENTAL

Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements. Randomized and will be blindly assessed.

Behavioral: Stepped Care Management

Interventions

Stepped Care Management BEHAVIORAL

Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.

Also known as: Intervention

Patient-centered care transition

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Seen in acute care emergency department or trauma center setting for injury
• At least three post traumatic concerns
• AND One of the following PTSD Checklist Score (PCL-C) greater than or equal to 35 Patient Health Questionnaire 9 - greater than or equal to 10 Any endorsement of suicidal ideation on the PhQ-9 Item 9

You may not qualify if:

• Non-English speaking
• Under 14 years of age
• Incarcerated
• Psychotic behavior
• Suffered head, spinal cord, or other severe injuries that prevent participation in the inpatient ward interview.

Sponsors & Collaborators

• University of Washington: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (3)

• Prater L, Bulger E, Maier RV, Goldstein E, Thomas P, Russo J, Wang J, Engstrom A, Abu K, Whiteside L, Knutzen T, Iles-Shih M, Heagerty P, Zatzick D. Emergency Department and Inpatient Utilization Reductions and Cost Savings Associated With Trauma Center Mental Health Intervention: Results From a 5-year Longitudinal Randomized Clinical Trial Analysis. Ann Surg. 2024 Jan 1;279(1):17-23. doi: 10.1097/SLA.0000000000006102. Epub 2023 Sep 25.

  PMID: 37747970 DERIVED

• Whiteside LK, Vrablik MC, Russo J, Bulger EM, Nehra D, Moloney K, Zatzick DF. Leveraging a health information exchange to examine the accuracy of self-report emergency department utilization data among hospitalized injury survivors. Trauma Surg Acute Care Open. 2021 Jan 28;6(1):e000550. doi: 10.1136/tsaco-2020-000550. eCollection 2021.

  PMID: 33553651 DERIVED

• Zatzick D, Russo J, Thomas P, Darnell D, Teter H, Ingraham L, Whiteside LK, Wang J, Guiney R, Parker L, Sandgren K, Hedrick MK, Van Eaton EG, Jurkovich G. Patient-Centered Care Transitions After Injury Hospitalization: A Comparative Effectiveness Trial. Psychiatry. 2018 Summer;81(2):141-157. doi: 10.1080/00332747.2017.1354621. Epub 2018 Mar 13.

  PMID: 29533154 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

Because this was a multifaceted intervention, the investigation did not yield information regarding which components of the treatment were effective in targeting specific outcomes. The intervention extended up until the 6-month injury time point.

Results Point of Contact

• Title: Douglas Zatzick
• Organization: University of Washington

dzatzick@uw.edu

2067446701

Study Officials

• Douglas Zatzick, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patient-centered care transition intervention

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: October 24, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 31, 2016
• Last Updated: November 21, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-11

Locations

US (1)